APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201

K080123 · Wako Chemicals USA, Inc. · CFR · Jul 17, 2008 · Clinical Chemistry

Device Facts

• Record ID: K080123
• Device Name: APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201
• Applicant: Wako Chemicals USA, Inc.
• Product Code: CFR · Clinical Chemistry
• Decision Date: Jul 17, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The APOLOWAKO HbA1c and APOLOWAKO Glucose are for the quantitative determination on the APOLOWAKO analyzer of hemoglobin A1c (HbA1c) % and glucose in whole blood samples.

Device Story

APOLOWAKO system is a point-of-care analyzer for quantitative determination of glucose and HbA1c in whole blood. System includes automated liquid dispenser, temperature-controlled reagent carousel, analysis compartment, and display. Input: whole blood sample in measurement disk. Operation: analyzer performs automated centrifugation to separate plasma for glucose testing; HbA1c testing involves dilution and hemolysis. Glucose measured via hexokinase/G-6-PDH enzymatic colorimetric reaction (absorbance at 340 nm). HbA1c measured via immune inhibition turbidimetric assay using anti-HbA1c antibodies. Output: glucose concentration (mg/dL) and HbA1c percentage. Used in point-of-care settings by clinicians/operators. Reagent information tags on units manage calibration, shelf-life, and lot parameters. Results assist healthcare providers in monitoring long-term glycemic control and diagnosing carbohydrate metabolism disorders.

Clinical Evidence

Method comparison study against FDA-cleared reference methods. Sample size: at least 387 samples for glucose and 352 for HbA1c. Results showed statistically significant correlation with slopes approaching 1.0 and y-intercepts approaching zero. Correlation coefficients (r) were 0.99 or better for both assays. Non-clinical testing included within-day and between-day imprecision (HbA1c CV 1.2-3.0%; Glucose CV 0.6-1.8%), linearity, and interference testing.

Technological Characteristics

Table-top POC analyzer (31cm x 47.5cm x 56cm, 25kg). Uses liquid reagents with information tags for parameter control (calibration, shelf-life, lot). Sensing principle: colorimetric, enzyme-based (glucose) and absorbance, immune inhibition (HbA1c). Automated plasma separation for glucose. Integrated temperature-controlled carrousel and automated liquid dispenser.

Indications for Use

Indicated for monitoring long-term glucose control in individuals with diabetes mellitus (HbA1c) and for the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia, and pancreatic islet cell carcinoma (Glucose).

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• CHOLESTECH LDX (k904082)
• CHOLESTECH GDX (k011933)
• Beckman Unicel DxC 800 (k042291)

Submission Summary (Full Text)

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KOSO123

#### Wako Diagnostics Wako

JUL 1 7 2008

# SECTION 9

# 510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is bcing submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. The assigned 510(k) number is K080123.

807.92 (a)(1): Namc: Wako Diagnostics Address: 665 Clyde Avenue, Suite B Mountain View, CA 94043 Phone: [phone] FAX: [phone] Contact: Peter Panfili, Ph.D.

#### 807.92 (a)(2): Device name- trade name and common name, and classification

#### Trade Name:

APOLOWAKO HbA1c and APOLOWAKO GLU

#### Common Name:

Test system for individual reporting of:

- HbAlc -
- ﺖ Glucose

#### Classification:

Glycosylated hemoglobin assay, Section 864.7470, Class II Glucose Test System, Section 862.1345, Class II

# 807.92 (a)(3): Identification of the legally marketed predicate device

CHOLESTECH LDX and CHOLESTECH GDX, Cholestech Corporation, Hayward, CA cleared under K904082 (LDX), K904082 (Glucose) and K011933 (GDX).

#### 807.92 (a)(4): Device Description

The APOLOWAKO analyzer is a fully-integrated POC test system that can perform up to six analytical tests per individual sample. For the HbA Ic test, whole blood, and not plasma, is used. For all other tests, the analyzer

Wako Chemicals USA, Inc. · 1600 Bellwood Drive · Richmond · VA · 23237 Email: [e-mail] · Phone: [phone] · Fax: [phone] Website: www.wakodiagnostics.com

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automatically separates plasma from whole blood for testing. Once the plasma has been separated, it is transferred to a cell on a measurement disk where the chemical reactions take place. The analyzer uses liquid reagents which are packaged into kits. Each kit contains 2 reagent units. Each unit is composed of two reagents and a calibrator. All of the reagents have a reagent information tag applied to the back of each bottle which controls the reagent parameters and conditions such as, calibration, reagent quantity, shelf-life, and lot number. The instrument contains an automated liquid dispenser, temperature controlled reagent carrousel, analysis compartment, and sample holder. The instrument is designed to automatically and constantly monitor the reagents, dispensing system, measurement disk, and measurement process to ensure that no erroneous results arc shown. The APOLOWAKO HbA1c and APOLOWAKO Glucose include hemoglobin A1c and glucose test reagents. The test system is designed for professional use and consists of a small table top instrument (31 cm wide x 47.5 cm high x 56 cm deep, weight: 25 kg).

# 807.92 (a)(5): Intended Use

The APOLOWAKO HbA1c and APOLOWAKO Glucosc are for the quantitative determination of hemoglobin Alc (HbAlc) % and glucose in whole blood samples.

# 807.92 (a)(6): Technological Similarities and Differences to the Predicate

| CHARACTERISTIC | APOLOWAKO Analyzer | Cholestech LDX & GDX Systems |
|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The APOLOWAKO HbA1c and<br>APOLOWAKO Glucose are for the<br>quantitative determination of<br>hemoglobin A1c (HbA1c) % and<br>glucose in whole blood samples. | "The Cholestech GDX A1C<br>Test...is indicated for monitoring<br>the average blood glucose levels of<br>people with diabetes as an indicator<br>of overall blood glucose control."<br>"...for the quantitative<br>determination of glucose in whole<br>blood." |
| Indications for Use<br>From CFR 864.7470 and CFR<br>862.1345 | Measurement of glycosylated<br>hemoglobin is used to assess the<br>level of control of a patient's<br>diabetes and to determine the<br>proper insulin dosage for a patient. | Measurement of glycosylated<br>hemoglobin is used to assess the<br>level of control of a patient's<br>diabetes and to determine the<br>proper insulin dosage for a patient. |

# Similarities / Differences between the APOLOWAKO HbA1c, APOLOWAKO Glucose and Established Predicate Devices (Cholestech LDX and GDX)

Wako Chemicals USA, Inc. · 1600 Bellwood Drive · Richmond · VA · 23237 Email: [e-mail] · Phone: [phone] · Fax: [phone] Website: www.wakodiagnostics.com

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| | Elevated levels of glycosylated<br>hemoglobin indicate uncontrolled<br>diabetes in a patient. | Elevated levels of glycosylated<br>hemoglobin indicate uncontrolled<br>diabetes in a patient. |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Measurement of glucose is used in<br>the diagnosis and treatment of<br>carbohydrate metabolism disorders,<br>including diabetes mellitus,<br>neonatal hypoglycemia and<br>idiopathic hypoglycemia. | Measurement of glucose is used in<br>the diagnosis and treatment of<br>carbohydrate metabolism disorders,<br>including diabetes mellitus,<br>neonatal hypoglycemia and<br>idiopathic hypoglycemia. |
| Sample | Whole blood | Whole blood |
| Sample Preparation | Venous whole blood sample | Finger stick or venous whole blood<br>sample |
| Calibration | Calibration is required at the time<br>the reagent is opened and lasts for<br>28 days or until expiration date. | No calibration is performed by the<br>user. |
| Methodology | Colorimetric, enzyme-based<br>(glucose); absorbance, immune<br>inhibition (HbA1c) | Colorimetric, affinity<br>chromatography |
| Testing Environment | Professional use, point-of-care | Prescription home use (A1c)<br>Professional use, point-of-care<br>(glucose) |

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| Reportable<br>range | HbA1c: 3-16.5%<br>Glucose: 18-350 mg/dL | HbA1c: 4-15%<br>Glucose: 50-500 mg/dL |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Precision | HbA1c: Total imprecision is 3% or<br>less across a range of 4.8% to<br>15.2% (mean values).<br>Glucose: Total imprecision is less<br>than 2% CV across a range of 72<br>mg/dL to 540 mg/dL (mean<br>values). | HbA1c: Total imprecision less<br>than 4% across a range of 5.7% to<br>9.4% (mean values).<br>Glucose: Total imprecision less<br>than 6.5% across a range of 103<br>mg/dL to 127 mg/dL. |
| Linearity | Assay linear throughout reportable<br>range | Assay linear throughout reportable<br>range |
| Interfering<br>Substances | No interference from high levels of<br>bilirubin (conjugated and<br>unconjugated), triglycerides,<br>hemoglobin (for glucose only),<br>sodium fluoride, (glucose only),<br>heparin sodium, EDTA-2Na,<br>ascorbic acid and others. Labile<br>HbA1c, carbamylated hemoglobin<br>or acetylated hemoglobin has no<br>influence on the HbA1c assay. | For HbA1c: No interference was<br>seen from high levels of bilirubin,<br>acetylsalicylic acid, caffeine,<br>acetaminophen, and hydroxyzine<br>dihydroxychloride. Elevated lipid<br>may interfere and cause low results<br>in this type of assay.<br>For glucose: There may be a 6-7%<br>difference in the glucose levels of<br>fingerstick and venous blood. (23<br>other substances had no effect). |

#### 807.92 (b)(1): Brief Description of Non-clinical Data

Evaluations were performed for within-day imprecision, between-day imprecision, linearity, and interfering substances. Those resulting data are summarized below.

#### HbA1c

Within-day imprecision, when evaluated at three levels of hemoglobin (low- 4.8 %, intermediate- 7.7 %, and high- 16.7 %), ranged from 1.2 % CV to 1.5 % CV. Between-day imprecision, when evaluated in duplicate over 10 days ranged from1.5 % CV to 3.0 % CV.

Results from linearity studies demonstrated that the hemoglobin A1c ratio (%) is linear throughout the reportable range.

Results from an interference testing showed hemoglobin A1c assay is not affected by high levels of glucose or bilirubin (conjugated or unconjugated).

Wako Chemicals USA, Inc. · 1600 Bellwood Drive · Richmond · VA · 23237 Email: [e-mail] · Phone: [phone] · Fax: [phone] Website: www.wakodiagnostics.com

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#### Glucose

Within-day imprecision, when evaluated at three levels of glucose (low-56 mg/dL, intermediate- 97 mg/dL, and high- 588 mg/dL), ranged from 0.6 % CV to 1.8 % CV. Between-day imprecision. when evaluated with in duplicate over 10 days, ranged 0.7 % CV to 1.1 % CV.

Results from linearity studies demonstrated that the glucose is linear throughout the reportable range.

Results from an interference testing showed that the glucose is not affected by high levels of hemoglobin, bilirubin (conjugated or unconjugated), triglycerides, ascorbic acid, EDAT-2Na, heparin sodium, or sodium fluoridc.

#### 807.92 (b)(2): Brief Description of Clinical Data

The method comparison study shows substantial equivalence to FDA cleared comparison methods for HbAlc and Glucosc. For each analyte at least 387 (352 for HbA1c) broadly distributed samples showed statistically significant correlation to the reference method with slopes approaching 1.0 and y-intercepts approaching zero. APOLOWAKO results were collected under rigorous conditions sufficient to meet the requirements for CLIA Waiver. The results show correlation coefficients of 0.99 or better for each assay.

#### 807.92 (b)(3): Conclusions from Non-clinical and Clinical Testing

Non-clinical and clinical testing was performed for the APOLOWAKO HbAlc and APOLOWAKO Glucose. The test system was shown to be safe and effective for its intended use.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Wako Chemicals USA, Inc. c/o Mr. Peter Panfili 665 Clyde Avenue, Suite B Mountain View, CA 94043

'JUL 1 7 2008

Re: k080123

Trade/Device Name: APOLOWAKO Glu and APOLOWAKO HbA1c Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CFR and LCP Dated: June 24, 2008 Received: June 30, 2008

Dear Mr. Panfili:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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Page 2 -

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet audiess at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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# Indication for Use

### 510(k) Number (if known): K080123

Device Name: The APOLOWAKO HbA1c and APOLOWAKO GLU

#### Intended Use

The APOLOWAKO HbA1c and APOLOWAKO Glucose are for the quantitative determination on the APOLOWAKO analyzer of hemoglobin A1c (HbA1c) % and glucose in whole blood samples.

#### Indications for Use

HbA1c- Measurement of % HbA1c is used to monitor long-term glucose control in individuals with diabetes mellitus.

Glucose- Measurement of glucose is used in the diagnosis and treatment of carbohydrate metabolism disorders, including diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia and pancreatic islet cell carcinoma.

Prescription Use X (21 CFR Part 801 Subpart D)

Over the Counter Use (21 CFR Part 801 Subpart C)

#### (PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

And/Or

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Carol C. Benson

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K08012-3